Drug Phases

Question 1

Phase 2

Answer 1

Up to 300 patients with the disease are enrolled to assess efficacy and toxicity

Question 2

Phase 3

Answer 2

Between 1,000 and 3,000 patients are entered into a randomized double blind study designed to confirm effectiveness compare the new tx with existing tx’s and study side effects further.

Question 3

Phase 4

Answer 3

Ongoing surveillance of the drug after it receives approval and is marketed to assess for rare or long term effects.

Question 4

Phase 1

Answer 4

Between 20 and 80 healthy volunteers are recruited to assess safety tolerance dosage ranges pharmacokinetics and pharmacodynamics.